BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERCI RETRIEVER X6

    MDR report key: 962825 · Received December 10, 2007

    Report

    Report Number
    2954917-2007-00027
    Event Type
    Malfunction
    Date Received
    December 10, 2007
    Date of Event
    November 6, 2007
    Report Date
    December 10, 2007
    Manufacturer
    CONCENTRIC MEDICAL, INC.
    Product Code
    NRY
    PMA / PMN Number
    K033736
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE DEVICE WAS NOT RETURNED TO CONCENTRIC MEDICAL, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THE MANUFACTURING RECORDS FOR MERCI RETRIEVER X6 DEVICES THAT WERE SHIPPED TO THE SITE, LOT NUMBER 32765, WERE REVIEWED AND NO ANOMALIES WERE FOUND THAT ARE RELATED TO THIS COMPLAINT. THE RETRIEVER INSTRUCTIONS FOR USE CONTAINS WARNINGS AND USE INSTRUCTIONS THAT ARE INTENDED TO REDUCE THE RISK OF FRACTURE.

    Description of Event or Problem · 1

    THIS INCIDENT INVOLVES TWO SEPARATE DEVICES, AS A RESULT, TOW SEPARATE MDRS ARE BEING SUBMITTED. (2954917-2007-000026 AND 2954917-2007-00027). THE PATIENT PRESENTED WITH A LEFT MCA STROKE. THE PHYSICIAN HAD AN ISSUE FROM THE START WITH THE BALLOON GUIDE BACKING BUT OF THE ICA DURING THE CASE. HE WAS USING A LONG INTRODUCER SHEATH. THE PHYSICIAN WENT UP WITH THE RETRIEVER X6 FOR 2 PASSES AND WAS ABLE TO OPEN THE VESSEL. THERE WAS RESIDUAL CLOT IN THE INFERIOR M2. THE PHYSICIAN DID A 3RD PASS WITH THE RETRIEVER X6. DURING THE 3RD PASS, THE PHYSICIAN MET WITH RESISTANCE UPON PULL BACK AND HE APPLIED 2 COUNTER-CLOCKWISE TORQUES ON THE DEVICE. THERE WAS SEPARATION OF THE MICROCATHETER FROM THE PLATINUM TIP DURING THIS TIME. HE CONTINUED TO PULL AND THE TIP FRACTURED. UPON REVIEW, HE HAD DEPLOYED THE DEVICE IN A SMALL BRANCH AND FELT THAT THE RETRIEVER X6 WAS NOT COMING BACK DUE TO SPASM. HE THEN TRIED TO RETRIEVER THE FRACTURED RETRIEVER X6 TIP WITH A RETRIEVER L5. HE WAS ABLE TO ENSNARE THE PROXIMAL LOOP OF THE FRACTURED TIP. HOWEVER, IT WEDGED AT THE MCA BIFURCATION. THE PHYSICIAN PAID CAREFUL ATTENTION TO THE PLATINUM JUNCTION ON THE RETRIEVER L5 DEVICE. HE DID TORQUE THE RETRIEVER L5 DEVICE, BUT NOT ANYMORE THAN TWO TIMES IN ANY ONE DIRECTION. DURING THE PASS THE RETRIEVER L5 FRACTURED. THE PHYSICIAN THAN PLACED A WINGSPAN STENT OVER THE RETRIEVER L5 AND PROXIMAL RETRIEVER X6. HE REGAINED FLOW THAT HE HAD ESTABLISHED WITH HIS ORIGINAL PASSES, BUT STILL HAD PART OF THE M2 OCCLUDED. HE WAS AT 8 HOURS AFTER ONSET OF SYMPTOMS, SO HE ELECTED TO END THE PROCEDURE. THE FOLLOW-UP CT SHOWED SMALL BLUSH (PH1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERCI RETRIEVER X6 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL, INC. 90066 32765

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR